MalabsorptionNCT02750787
Use of a Peptide-based Formula in an Adult Population
A study testing Nutritional Study Product in people with Malabsorption, run by Abbott Nutrition at 1 site in Canada.
Trial summary
The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malabsorption
- What is being tested?
- Nutritional Study Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age.
- Subject has chronic malabsorption or maldigestion.
- Subject requires supplemental nutrition as assessed by a clinician.
- Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period.
Who cannot join
- Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study.
- Subject has current active malignant disease or was treated within the last 6 months for cancer.
- Subject has a history of diabetes mellitus.
- Subject is pregnant as demonstrated by a urine pregnancy test.
- Subject has severe auto immune disease and is on immuno-modulating therapy.
- Subject has a history of allergy to any of the ingredients in the study product.
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- Subject has active HIV.
- Subject has a known aversion to flavor of product being tested.
- Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption.
- Subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product.
- Subject is taking part in another non-Sponsor approved clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Use of a Peptide-based Formula in an Adult Population
The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.
- Conditions
- Malabsorption
- Being tested
- Nutritional Study Product
- Medical subject headings
- Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Study ProductOther
Two 220 ml servings per day
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Study Product | Experimental | A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function. Receives: Other: Nutritional Study Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Product Consumption
Subject Diary
Measured: Day 1 to Day 23
Secondary outcomes (3)
Body Mass Index
Calculated from Height and Weight
Measured: Change from Screening to Day 23
Medication Use
Subject Interview of Dose, Unit and Frequency
Measured: Screening to Study Day 23
Adverse Events
Measured: Screening to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalabsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Nelson, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750787
- Sponsor's protocol ID
- DA12
- Status last verified
- Jul 2017
- First submitted
- 19 Apr 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Use of a Peptide-based Formula in an Adult Population
- ClinicalTrials.gov ID
- NCT02750787
- Acronym / sponsor ID
- DA12
- Conditions
- Malabsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Study Product | Experimental | Other: Nutritional Study ProductA ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 18 years of age.
- Subject has chronic malabsorption or maldigestion.
- Subject requires supplemental nutrition as assessed by a clinician.
- Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period.
Key exclusion criteria (11 listed)
- Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study.
- Subject has current active malignant disease or was treated within the last 6 months for cancer.
- Subject has a history of diabetes mellitus.
- Subject is pregnant as demonstrated by a urine pregnancy test.
- Subject has severe auto immune disease and is on immuno-modulating therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional Study ProductTwo 220 ml servings per day | Other | Nutritional Study Product |
Primary outcome
Study Product Consumption
Time frame: Day 1 to Day 23
Subject Diary
3 secondary outcomes
Body Mass Index
Time frame: Change from Screening to Day 23
Medication Use
Time frame: Screening to Study Day 23
Adverse Events
Time frame: Screening to Day 25
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Nelson, PhD study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Study Product in people with Malabsorption, run by Abbott Nutrition at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Product Consumption (time frame: Day 1 to Day 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.